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Completed

NCT Number: NCT01956591

Long Term Results of the Use of Oxybutynin for the Treatment of Hyperhidrosis

Evaluate the long term efficacy and side effects of oxybutynin in the treatment of hyperhidrosis.

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Key information

Conditions

Hyperhidrosis Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Israelita Albert Einstein

São Paulo, 05652000, Brazil

About this study

This retrospective study aims to evaluate the medical charts of patients who were treated with oxybutynin for at least six months for primary hyperhidrosis. The investigators variables of interest are: (1) quality of life before pharmacological therapy and after six weeks, (2)self-perception of improvement in hyperhidrosis after six weeks of treatment and on last visit (whenever this occur, as long as this happens after six months), (3) side effects related to drug use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary hyperhidrosis
  • At least 180 days of treatment with oxybutynin

Exclusion criteria

  • Incomplete medical chart
  • Patients with glaucoma

Treatment and study plan

Oxybutynin

Drug

All patients are treated with oxybutynin for hyperhidrosis. Usual maintenance dose is 10mg/day, but dose may vary according to weight, efficacy and side effects. Our standard protocol starts with 2.5mg/day in the first 7 days, progresses to 5mg/day for 14 days and then reaches the usual maintenance dose of 10mg/day afterwards.

Primary outcomes

  1. Quality of life

    Time frame: 1 day before treatment

    Evaluate the Quality of life (using a standardized questionnaire for hyperhidrotic patients) before pharmacological treatment

  2. Quality of life

    Time frame: Forty-two days after treatment

    Evaluate the Quality of life (using a standardized questionnaire for hyperhidrotic patients) after 42 days of treatment

Secondary outcomes

  1. Perception of improvement in excessive sweating

    Time frame: After 42 days of treatment

    We want to analyze the patient's self perception (grades 0 to 10) of amelioration in sweating after forty-two days of treatment

  2. Perception of improvement in excessive sweating

    Time frame: 1 day (On the last medical visit)

    We want to analyze the patient's self perception (grades 0 to 10) of amelioration in sweating on the last medical visit (whenever this happens).

Other outcomes

  1. Side effects in the use of oxybutynin for hyperhidrosis

    Time frame: After 42 days of treatment

    Assess the side effects that have been reported on patient's charts, such as: dry mouth, constipation, headache, glaucoma, bowel obstruction and any other side effect reported

  2. Side effects in the use of oxybutynin for hyperhidrosis

    Time frame: 1 day )On the last medical visit)

    Assess the side effects that have been reported on patient's charts, such as: dry mouth, constipation, headache, glaucoma, bowel obstruction and any other side effect reported on the last medical return of the patient

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Official study title

Retrospective Evaluation of Long Term Use of Oxybutynin in the Pharmacological Treatment of Primary Hyperhidrosis

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Oct 8, 2013
Registry last updated
Oct 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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